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EC number: 700-300-8 | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The procedures used in the test are in compliance with the OECD Guideline for Testing of Chemicals No. 406.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- temperature fell below the specified range by 1 °C on one occasion
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- reaction mass of Lycopyl salt isomers
- IUPAC Name:
- reaction mass of Lycopyl salt isomers
- Details on test material:
- - Name of test material (as cited in study report): (2E,4E,6E)-(3,7,11-Trimethyl-dodeca-2,4,6,10-tetraenyl)-triphenyl-phosphonium acetate
- Physical state: clear yellow liquid
- Lot/batch No.: P19-39.5
- Storage condition of test material: In refrigerator at 2-8 °C, protected from light, covered with Nitrogen
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: D. Hall, Darley Oaks, Burton-on-Trent, England
- Age at study initiation:
- Weight at study initiation: 300-350 g
- Housing: up to five in stainless steel cages
- Diet (e.g. ad libitum): diet pellets SQC FD1 guinea pig diet with added vitamin C (Special Diet Services, Witham, England)
- Water (e.g. ad libitum): mains drinking water
- Acclimation period: pre-test for five days, seconder intradermal range finding test for 13 days, main test for 26 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-22
- Humidity (%): 52-69
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: To:
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal and epicutaneous
- Vehicle:
- water
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Details on study design:
- RANGE FINDING TESTS:
A ranging study was performed in one animal for intradermal injection. 7 days previously, the animal had been treated with 4 intradermal injections of a 1:1 mixture of Freund's Complete Adjuvant (FCA) and water.
0.1 mL aliquots of 50 %, 25 %, 10 %, 5 %, 1 % and 0.5 % (v/v) concentrations of the test article in water were injected dermally into the flanks of the guinea pig. The animal was examined on the day of dosing and then daily thereafter for a further 2 days. The resulting intradermal response was unacceptably severe. Test article concentrations of 0.1 %, 0.05 % and 0.01 % (v/v) were administered to an additional FCA/water treated animal and the injection sites examined daily for 6 days. All concentrations used in this second test produced severe responses. A concentration of 0.005 % (v/v) was anticipated to not provoke an unacceptable skin response.
4 animals were pretreated with 1:1 FCA/water as described above. The concentrations used in the topical range finding study were undiluted test article and 50 %, 25 %, 12.5 % (v/v) concentrations of the test article in water. 4 patches each saturated with a different concentration of the test article were placed onto the skin (previously clipped free of fur) on each flank. The site was occluded and the patches were held in place for 24 hours. Twenty four and 48 hours after removing the patches, the animals were examined under standard light and any reaction at the treated site was assessed. The test showed that undiluted test article was minimally irritant and suitable for the topical induction stage. A 50 % (v/v) concentration of the test article in water was the maximum non irritant concentration and was selected for use for the
MAIN STUDY
A. INDUCTION EXPOSURE: intradermal
- No. of exposures: three pairs of intradermal injections
- Exposure period:
- Test groups: 20 animals, randomly selected
- Control group: 10 animals, randomly selected
- Site: dorsal area between the shoulders
- Concentrations: Test group: 50 % v/v FCA emulsified in water; 0.005 % v/v test article in water; 0.005 % v/v concentration of the test article in a 1:1 emulsion of FCA and water; Control group: 50 % v/v FCA emulsified in water; water; water mixed with a 1:1 emulsion of FCA and water to give a vehicle concentration of 50 % v/v
A. INDUCTION EXPOSURE: epicutaneous
- No. of exposures: one patch over the injection sites (4 x 2 cm), skin treated with 0.5 mL of 10 % w/v sodium lauryl sulphate in light liquid paraffin
- Exposure period: seven days after intradermal induction
- Test groups: 20 animals
- Control group: 10 animals
- Site: dorsal area between the shoulders
- Frequency of applications: once
- Duration: occlusive for 48 hours
- Concentrations: undiluted
B. CHALLENGE EXPOSURE
- No. of exposures: one patch on each flank of testing animals
- Day(s) of challenge: fourteen days after topical induction
- Exposure period:
- Test groups: 20 animals
- Control group: 10 animals
- Site: right and left flanks
- Concentrations: 50 % v/v of test article in water
- Evaluation (hr after challenge): twenty four and 48 hours after removal of patches
OTHER: Mercaptobenzothiazole was used as a positive control as this is known to be a sensitiser. The material was administered as a 10 % w/v concentration in light liquid paraffin for the intradermal injection phase. Seven days after administration of the intradermal injections, MBT was administered topically to animals in the test group at a concentration of 10 % w/v in acetone whilst animals in the control group were treated with acetone alone. Fourteen days after this topical application, a 10 % w/v concentration of MBT in acetone was applied to the left flank of all test and control animals whilst acetone alone was applied to the right flank. Both sites were then occluded for 24 hours. Skin sites were examined and the skin responses were scored 24 and 48 hours ater the end of the occlusion period. - Positive control substance(s):
- yes
- Remarks:
- Mercaptobenzothiazole (MBT)
Results and discussion
- Positive control results:
- Four of the 10 test animals exhibited positive responses to challenge with 10 % MBT at the 24 and the 48 hours observations, resulting in a response incidence of 40 %. None of the test animals responded to challenge with the vehicle at any of the observations.
None of the control animals responded to challenge with either 10 % MBT or the vehicle at any of the observations.
These results confirm that MBT is a moderate sensitiser under the conditions of the study and the test system is therefore considered to be valid.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50 % v/v test article in water
- No. with + reactions:
- 9
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50 % v/v test article in water. No with. + reactions: 9.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50 % v/v test article in water
- No. with + reactions:
- 12
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50 % v/v test article in water. No with. + reactions: 12.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 50 % v/v test article in water
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 50 % v/v test article in water. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 50 % v/v test article in water
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 50 % v/v test article in water. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 10 % MBT
- No. with + reactions:
- 4
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: 10 % MBT. No with. + reactions: 4.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 10 % MBT
- No. with + reactions:
- 4
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: positive control. Dose level: 10 % MBT. No with. + reactions: 4.0. Total no. in groups: 10.0.
Any other information on results incl. tables
Table 1: Individual skin responses during the challenge phase
Group |
Cage no. |
Animal no. |
50 % test article |
Water |
||
Test |
11 |
1 |
0 |
1 |
0 |
0 |
2 |
1 |
0 |
0 |
0 |
||
3 |
0 |
0 |
0 |
0 |
||
4 |
0 |
0 |
0 |
0 |
||
5 |
1 |
1 |
0 |
0 |
||
12 |
1 |
1 |
1 |
0 |
0 |
|
2 |
1 |
1 |
0 |
0 |
||
3 |
0 |
1 |
0 |
0 |
||
4 |
1 |
1 |
0 |
0 |
||
5 |
1 |
1 |
0 |
0 |
||
13 |
1 |
0 |
1 |
0 |
0 |
|
2 |
0 |
0 |
0 |
0 |
||
3 |
1 |
1 |
0 |
0 |
||
4 |
0 |
0 |
0 |
0 |
||
5 |
0 |
0 |
0 |
0 |
||
14 |
1 |
1 |
2 |
0 |
0 |
|
2 |
0 |
0 |
0 |
0 |
||
3 |
1 |
1 |
0 |
0 |
||
4 |
0 |
1 |
0 |
0 |
||
5 |
0 |
0 |
0 |
0 |
||
Control |
15 |
1 |
0 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
||
3 |
0 |
0 |
0 |
0 |
||
4 |
0 |
0 |
0 |
0 |
||
5 |
0 |
0 |
0 |
0 |
||
16 |
1 |
0 |
0 |
0 |
0 |
|
2 |
0 |
0 |
0 |
0 |
||
3 |
0 |
0 |
0 |
0 |
||
4 |
0 |
0 |
0 |
0 |
||
5 |
0 |
0 |
0 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information
- Conclusions:
- Based upon the results of the experiment, it is concluded that Ro 44-9567/002 exhibits a moderate to strong sensitisation potential on the guinea pig under the conditions of the study.
- Executive summary:
In order to assess the skin sensitisation potential of Ro 44 -9567/002, the Maximisation Test in accordance with OECD Guideline No. 406 was carried out in 30 (20 test and 10 control) female albino guinea pigs.
The intradermal induction of sensitisation was carried out with 0.005 % v/v solution of the test article in water or in emulsion with Freund's Complete Adjuvent. The epicuataneous induction of sensitisation was conducted with undiluted test article under occlusion. Two weeks after the epidermal induction, the challenge was completed by epicutaneous application of the test article in the highest non irritating concentration, i.e., 50 % v/v in water (as determined in the range finding phase of the study) under occlusive dressing.
13 of the test animals exhibited positive skin reactions after challenge with 50 % v/v test article in water (Table 1), giving a response incidence of 65 %. None of the animals in the control group responded positively to challenge with 50 % v/v test article in water.
Based upon the results of the experiment, it is concluded that Ro 44-9567/002 exhibits a moderate to strong sensitisation potential on the guinea pig under the conditions of the study.
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